Approximately 25% of the total comments addressed
Post# of 148187
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Posted On: 07/07/2021 6:51:10 PM
Quote:
Approximately 25% of the total comments addressed required clarifications of analytics and assessments, including the revalidation of the receptor occupancy to assist the FDA in its substantive review of the BLA.
The creator of the test IncellDX would be responsible for validation by testing parameters that could effect the test. So now we know.
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